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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000277-40 | EudraCT Number |
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This study is designed to investigate the absorption, distribution, metabolism and elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-labeled RO5285119 | Experimental | Single oral dose - drinking solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5285119 | Drug | Single oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) [14C]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1 |
| Measure | Description | Time Frame |
|---|---|---|
| Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered | Up to Day 17 | |
| Pharmacokinetic profile of total drug-related material, RO5285119 and its metabolites, as appropriate in plasma, estimated Cmax | Up to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of dose recovered as total radioactivity, i.e. relative abundance of RO5285119 and its metabolite(s) in plasma, urine and feces | Up to Day 17 | |
| Incidence of adverse events | Up to 28 days after the last dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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